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Countries need to develop and align mHealth policies, experts say

By Mary Mosquera, Senior Editor
While mobile health applications are burgeoning throughout the world and emerging as a vital means of care in developing countries, governments aren't keeping up with policies and regulations to support their development.

That's the sentiment of mobile health experts from several regions of the world who participated in "Global Policy and Regulatory Perspectives of mHealth," a Super Session held last Wednesday at the mHealth Summit.

In the United States, the Food and Drug Administration is trying to strike a balance in its regulatory policies. Many mHealth apps don't require FDA oversight because they focus more on consumer wellness, said William Maisel, deputy director and chief scientist of the FDA's Center for Devices and Radiological Health.

"What we need to see is something that converts a smartphone into a medical device that we regulate or an accessory to a device that we regulate, like an EKG machine," he said.

For example, he announced that the FDA had cleared that same day the first glucose meter to connect to an Apple iPhone, the iBGStar from Sanofi U.S. and its partner, AgaMatrix.

Gwendoline Ramokgopa, the deputy minister of health in South Africa, said numerous mobile health pilots are ongoing in her country, but they aren't scalable or interoperable, in part because of limited funding, insufficient data standards and because "regulations and policies have fallen short."

Despite the challenges, "we believe that technology can help us to democratize the health systems," she said.

Mexico has no regulations specifically on mobile health applications.

"We have to approach the application in a case-by-case process with the authorities on behalf of our clients," said Lourdes Motte-Murguie, a senior partner and president of consultant PPAL who previously held positions in Mexico's Ministry of Health.

However, some efforts may ease the situation. Motte-Murguie said she's hoping the government will implement agreements that allow devices that have been approved by the U.S. FDA and mHealth Canada to be introduced quickly into Mexico.

The examples from all three countries point to the need for policies at the country level that are then harmonized among other nations, said Joseph Smith, chief medical and science officer at the San Diego-based West Wireless Health Institute.

This technology has solved for the first time the proximity problem in healthcare, he said. Patients no longer have to be close to a practitioner.

The challenge, Smith added, is this: "Are we going to be able to unleash the real capability of the technology so that when a patient in South Africa desperately needs the clinical insight of a specialist that only exists in Detroit, Mich., that that can actually happen? Or, are we forever bound up by geographical restraints, even though this technology separates the requirement for proximity?"